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临床试验/CTRI/2025/07/091713
CTRI/2025/07/091713尚未招募2/3 期

Efficacy of nutool-e-raas with roghan-e-khashkhash in insomnia (sahar)-an open labelled interventional clinical trial

State unani medical college and hospital1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年8月18日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
46
试验地点
1
主要终点
Insomnia

研究概览

简要总结

Insomnia is a Latin word derived from insomnia which is composed of ‘in’ means not and ‘somnus’ means sleep which means no sleep . Insomnia is an acute or chronic inability to initiate or maintain sleep adequately at night at least 3 night a week for at least 3 months . An estimated (6%-10%) of the adult population suffer from insomnia. which is more common in women. The prevalence of insomnia is increased with advancing age. It may be due to continuous fluctuation in hormones. it is estimated that 40% of all insomnia patient have a co-existing psychiatric disorder. depression is most common disease due to due to its chronicity and insomnia is associated with substantial impairment in an individual quality of life. In allopathic system of medicine treatment Options for insomnia are pharmacologic treatment as sedative like Triazolam (Halcion) or Zolpidem (Ambien) or rapidly acting drugs are more effective, such as flurazepam, clonazepam, Quazepam (Doral) for patient with persisting insomnia, but these are not curative for insomnia rather these drug may cause side effect like, debilities, loss of libido, laziness, addiction etc, which is again call for an alternative management.

Unani physician have been successfully treating insomnia (sahar) through Nutool (irrigation therapy) since ancient times, but scientific documentation is not available. So in the light of aforementioned facts, i am determined to conduct a clinical trial to appraise the efficacy of Nutool (irrigation therapy) in management of Sahar (insomnia). Nutool is a regimenal therapy (Ilaj-bit-tadbeer). and it is a novel method, in which decoction of certain drugs or medicated oils are poured over specific sites at certain height in some specific disease. In unani system of medicine, the treatment of Sahar (insomnia) is the restoration of brain homeostasis through various unani tadbeer (therapies), along with dietary components, mubarrid and murattib advia, among them NUTOOL therapy is one of the most commonly used tadbeer for the management of Sahar . The present study has been designed to evaluate the efficacy of nutool-e-raas (irrigation of head) with Roghan-e-Khaskhash in the management of insomnia

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patient with age 20 years to 60 years of all gender.
  • Clinically diagnosed Patient having a insomnia severity index (ISI) score (more than
  • less than 21).
  • Patient who will give consent and able to do follow up.

排除标准

  • Pregnant and lactating women.
  • Patient having any systemic and metabolic diseases.
  • Unstable mentally retarded and bed ridden patient.
  • Patient with history of trauma and accident involving skull.
  • Concomitant skin disease involving the skull like tinea capitis,scalp psoriasis,etc.
  • 6.Patients on sedative and hypnotic drugs, hormonal therapy or any other psychosomatic drug.
  • Patients who do not report for follow up and who refuses to join the study.

结局指标

主要结局

Insomnia

时间窗: 7th, 14th, 23rd Day

次要结局

  • QOL (SF-36)(HAQ - health assessment questionnaire)

研究者

发起方
State unani medical college and hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Ishaq Ahmad

State Unani Medical College and hospital himmatganj Prayagraj, UP

研究点 (1)

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